Manager, Regulatory Affairs and Compliance

📋 Description

• Ensures alignment with relevant regulatory / accrediting bodies (e.g., FDA, CLIA, CAP, ISO, ASHI
• Monitors effectiveness of the QMS through internal audits, indicators and reviews
• Acts as primary point of contact and liaison for regulatory and accrediting bodies
• Coordinates and facilitates external inspections and audits
• Promotes safe and lawful operations; Ensures inspection-readiness
• Reports regulatory to executive leadership; Prepares compliance dashboards

🎯 Requirements

• Bachelor's degree, preferably in a chemical, physical, biological science, or Medical Laboratory
• Minimum of 3-5 years of experience in a laboratory environment, with significant experience
• In-depth knowledge of relevant federal, state, and local regulations and standards (e.g., CLIA
• A Master’s Degree or professional certification (e.g., Certified Regulatory Compliance Manager or

🎁 Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays